TRK-3 Performance of Pachymetry

February 29, 2024 updated by: Topcon Corporation

TRK-3 Agreement and Precision of Pachymetry Function

To evaluate the performance of a new tonometer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Topcon Healthcare Innovation Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Subjects who have healthy cornea

Description

Inclusion Criteria:

  1. Provide voluntary written consent for participation in the study.
  2. Age at least 22 years old at the time of informed consent.

Exclusion Criteria:

  1. Ocular condition that may affect the ability to perform corneal measurement (e.g., corneal perforation, bullous keratopathy, nystagmus)
  2. Have or is suspected to have an ocular infection in either eye.
  3. Otherwise considered unsuitable for the study by the investigator
  4. Unable to tolerate ophthalmic testing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal cornea
Device: Kerato-Refracto Tonometer
measures pressure inside the eye and thickness of the cornea.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cornea thickness
Time Frame: 1 day
Thickness of the cornea
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Topcon Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2024

Primary Completion (Actual)

February 26, 2024

Study Completion (Actual)

February 26, 2024

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

February 1, 2024

First Posted (Actual)

February 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • THQ-THINC-2023-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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